Time to disease progression [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]

Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.

Overall survival (OS) (Discontinued as of 4/25/2014) [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]

The Kaplan-Meier method will be used to estimate OS. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.

Progression-free survival (PFS) [ Time Frame: Time from start of treatment to time of progression, assessed up to 6 months ] [ Designated as safety issue: No ]

The Kaplan-Meier method will be used to estimate PFS. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.

Duration of overall CA-125 response [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]

Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible. The the effect of CA-125 antigen on objective tumour response will be performed using logistic regression techniques, and on patient survival using Cox proportional hazards regression methods.

Incidence of toxicity graded according to National Cancer Institution Common Terminology Criteria for Adverse Events version 3.0 [ Time Frame: Up to 4 years ] [ Designated as safety issue: Yes ]

A Phase 2 Study of AZD2171 in Recurrent or Persistent Ovarian, Peritoneal, or Fallopian Tube Cancer

Brief Summary

This phase II trial is studying how well cediranib maleate works in treating patients with persistent, recurrent, or refractory advanced ovarian epithelial, peritoneal cavity, or fallopian tube cancer. Cediranib maleate may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Unknown status

Enrollment ICMJE

74

Completion Date

Not Provided

Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria:

Patients must have histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that has recurred or is refractory to initial therapy; patients must have received platinum-based chemotherapy before entry into this protocol

Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm with spiral computed tomography (CT) scan OR patients must have evidence of progression based on an elevated CA-125 (defined as a value of > 2 x upper limit of normal [ULN] documented on two separate determinations made > 2 weeks apart) if the physical exam is normal and CT scan of the chest/abdomen/pelvis, has a disease volume < 1 cm in maximum diameter

Patients may have received no more than one prior chemotherapy regimen (i.e. initial first-line chemotherapy only)

Women of child-bearing potential must have a negative pregnancy test prior to study entry; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately

Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

Patients who have had chemotherapy, radiotherapy, or major surgery within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier

Patients with borderline tumors or tumors of low malignant potential

Patients with current bowel obstruction

Patients may not be receiving any other investigational agents nor have participated in an investigational trial within the past 30 days

Patients with known brain metastases should be excluded from this clinical trial

History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD2171 (cediranib maleate)